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Study for the Treatment of Ulcerative Colitis With Adacolumn (Companion to US Study 512-04-205)

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ClinicalTrials.gov Identifier: NCT00219414
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 27, 2007
Sponsor:
Information provided by:
Otsuka Frankfurt Research Institute GmbH

Brief Summary:
The purpose of the study is to demonstrate the safety and effectiveness of the Adacolumn Apheresis System to treat the signs and symptoms of ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: Adacolumn Apheresis System Phase 4

Detailed Description:
Study Type: Interventional Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Study Type : Interventional  (Clinical Trial)
Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 2005
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Primary Outcomes: Effectiveness will be primarily evaluated at Week 12 by disease activity index (DAI) score; Safety will be evaluated by determining the frequency and severity of adverse events.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Accepts Healthy Volunteers:   No

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00219414


Sponsors and Collaborators
Otsuka Frankfurt Research Institute GmbH
Investigators
Principal Investigator: Robert Lofberg, Prof. IBD-unit, Dept. of Gastroenterology, HMQ Sophia Hospital, Stockholm, Sweden
Principal Investigator: Toshifumi Hibi, Prof. Keio University, Tokyo, Japan

ClinicalTrials.gov Identifier: NCT00219414     History of Changes
Other Study ID Numbers: 512-04-205-CS
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 27, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases